Targeting Inflammation in Acute Coronary Syndrome Using C... | NCT00754819

Studies
Targeting Inflammation in Acute Coronary Syndrome Using Colchicine

NCT00754819

Sponsor

Hamilton Health Sciences Corporation

Status

Completed

Last Update Posted

Oct 8, 2009Estimated

Enrollment

80Actual

Phase

Phase 2Phase 3

Conditions

Acute Coronary Syndrome

Interventions

Colchicine
Placebo

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Sep 16, 2008

First Submission Date that Met QC Criteria

Sep 16, 2008

First Posted Date

Sep 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2009

Last Update Posted Date

Oct 8, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the effect of colchicine on high sensitivity C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute coronary syndromes.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Colchicine 1mg daily oral	Drug: Colchicine
2	Placebo Comparator	Placebo 1 capsule daily oral	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colchicine	Drug	1mg once daily	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine the effect of low dose colchicine on hs-CRP.		30 days

Secondary Outcomes

Measure	Description	Time Frame
To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events		30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with a diagnosis of acute coronary syndrome who are > 18 years old and who do not have any contraindication to colchicine.

Exclusion Criteria:

Contraindication to colchicine including any of the following:
- hypersensitivity to colchicine
- severe renal, hepatic or gastrointestinal disorder
- blood dyscrasias (myelodysplasia cytopenias etc)
Concurrent use of moderate-strong CYP3A4 inhibitors (a complete list is appended in the full protocol)
Known severe liver disease and/or elevated transaminases > 1.5x the upper limit of normal
Estimated GFR < 50 ml/min
Pregnant or lactating women or women not protected by a reliable contraception method
Current treatment with colchicine at enrollment
Active infection or systemic inflammation eg active rheumatoid arthritis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
John Eikelboom, FRACP FRCPA	McMaster University	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Hamilton General Hospital		Hamilton	Ontario	L8L2X2	Canada

Type	Date	Date Unknown
Release	Jan 4, 2017
Reset	Feb 23, 2017

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jan 4, 2017			Feb 23, 2017

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D000470	Alkaloids
D006571	Heterocyclic Compounds